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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, physiological, patient(with arrhythmia detection or alarms)
510(k) Number K123074
Device Name IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS
Applicant
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
55 NORTHERN BLVD., SUITE 200
GREAT NECK,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
55 NORTHERN BLVD., SUITE 200
GREAT NECK,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number870.1025
Classification Product Code
MHX  
Date Received10/01/2012
Decision Date 07/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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